Device GUDID : 04046445409691

Medical Device Brand Name : VenoTrain impuls
(model 20760031220322)

Device Information

Company Name

BAUERFEIND AG

Company name associated with the labeler DUNS Number entered in the DI Record.

Brand Name

VENOTRAIN IMPULS

The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol.

Version or Model Number

20760031220322

The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler.

Catalog Number

N/S (NOT SPECIFIED)

The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product.

Device Description

N/S (NOT SPECIFIED)

Additional relevant information about the device that is not already captured as a distinct GUDID data attribute.

Device Status

Device Record Status

PUBLISHED

DI Record Publish Date

2016-10-06

Indicates the date the DI Record is published and available via Public Search.

Commercial Distribution End Date

N/S (NOT SPECIFIED)

Indicates the date the device is no longer held or offered for sale by the labeler on record. See 21 CFR 807.3(b) for exceptions. The device may or may not still be available for purchase in the marketplace.

Commercial Distribution Status

IN COMMERCIAL DISTRIBUTION

Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b).

Identifiers

Device Identifier Type

PRIMARY

Device Identifier Type

Device Unique Identifier

04046445409691

Device Unique Identifier Number

Issuing Agency

GS1

Organization accredited by FDA to operate a system for the issuance of UDIs.

Contains DI Number

N/S (NOT SPECIFIED)

Contains DI Number

Quantity Per Package

N/S (NOT SPECIFIED)

The number of packages with the same Primary DI or Package DI within a given packaging configuration.

Package Discontinue Date

N/S (NOT SPECIFIED)

Indicates the date this particular package configuration is discontinued by the labeler.

Package Status

N/S (NOT SPECIFIED)

Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b).

Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code.

GMDN PT Definition

A TUBE-LIKE GARMENT MADE OF ELASTIC MATERIAL (E.G., CIRCULAR KNIT NYLON AND SPANDEX YARNS) THAT EXERTS A PRESSURE ACROSS THE LIMB UPON WHICH IT IS FITTED (TYPICALLY A LEG, BUT SOME TYPES MAY BE USED ON AN ARM), PRIMARILY TO IMPROVE VENOUS RETURN TO TREAT/PREVENT ONE OR MORE DISORDERS OF CIRCULATION [E.G., OEDEMA, DEEP VEIN THROMBOSIS (DVT), VARICOSIS]. IT MAY BE INTENDED TO APPLY A GRADUATED PRESSURE ACROSS A LIMB, HOWEVER IT IS NOT INTENDED TO SUPPORT AN INJURED JOINT. IT IS NORMALLY AVAILABLE [NON-PRESCRIPTION] OVER-THE-COUNTER (OTC) FOR HOME-USE AND/OR FOR HOSPITALIZED OR INSTITUTIONALIZED PATIENTS. THIS IS A SINGLE-USE DEVICE.

Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code.

Contacts

Contact Email

N/S (NOT SPECIFIED)

Email for the Customer contact; To be used by patients and consumers for device-related questions.

Contact Phone

N/S (NOT SPECIFIED)

Phone number for the Customer contact; to be used by patients and consumers for device-related questions.

Contact Phone Extension

N/S (NOT SPECIFIED)

Phone Extension for the Customer contact.

Product Sizes

Size Type

N/S (NOT SPECIFIED)

Dimension type for the clinically relevant measurement of the medical device.

Size Value

N/S (NOT SPECIFIED)

Numeric value for the clinically relevant size measurement of the medical device.

Storage and Handling Type

Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure.

Storage and Handling High Value

N/S (NOT SPECIFIED)

Indicates the high value for storage and handling requirements.

Storage and Handling High Unit of Measure

N/S (NOT SPECIFIED)

Storage and Handling Low Value

N/S (NOT SPECIFIED)

Indicates the low value for storage and handling requirements.

Storage and Handling Low Unit of Measure

N/S (NOT SPECIFIED)

Storage and Handling Special Condition text

N/S (NOT SPECIFIED)

Indicates any special storage requirements for the device.

Sterilization

Device Packaged as Sterile

FALSE

Indicates the medical device is free from viable microorganisms. See ISO/TS 11139.

Requires Sterilization Prior to Use

FALSE

Indicates that the device requires sterilization prior to use.

Sterilization Methods

N/S (NOT SPECIFIED)

Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient.

Device Characteristics

Device Count

1

Number of medical devices in the base package.

Device Subject to Direct Marking (DM), but Exempt

FALSE

The device is exempt from Direct Marking requirements under 21 CFR 801.45.

Device Exempt from Premarket Submission

FALSE

FDA Premarket submission is not required for this device.

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

FALSE

Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.

Kit

FALSE

Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device.

Combination Product

FALSE

Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device in this case.

For Single-Use

TRUE

Indicates that the device is intended for one use or on a single patient during a single procedure.

Lot or Batch Number on Label

FALSE

The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.

Serial Number on Label

FALSE

The number that allows for the identification of a device, indicating its position within a series. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.

Manufacturing Date on Label

FALSE

The date on which a device is manufactured. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.

Expiration Date on Label

FALSE

The date by which the label of a device states the device must or should be used. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.

Donation Identification Number on Label

TRUE

The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.

Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Choosing 'Yes' indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber".

Device labeled as "Not made with natural rubber latex"

FALSE

Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked.

Magnetic Resonance Imaging Safety Status

LABELING DOES NOT CONTAIN MRI SAFETY INFORMATION

Indicates the MRI Safety Information, if any, that is present in the device labeling. Please see the ASTM F2503-13 standard for more information.

Prescription Use (Rx)

FALSE

Indicates that the device requires a prescription to use.

Over the Counter (OTC)

FALSE

Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC).

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